Global Pharmaceutical IT/OT Strategy & Consultancy
Our Expertise
1. Global Strategic Experience
24 years defining production site strategies at a global level across pharmaceutical manufacturing operations. Extensive experience in harmonizing IT/OT systems across multiple sites, implementing enterprise-wide technology roadmaps, and driving digital transformation initiatives in GxP-regulated environments.
2. Operations Improvement
Deep understanding of production site processes to identify optimization opportunities. Define relevant use cases with comprehensive business cases, prioritize initiatives based on ROI and strategic impact, and deliver measurable operational improvements that drive efficiency and competitiveness.
3. Project Delivery
Support projects by defining deliverables for full vertical integration from shop floor equipment to ERP systems. Expertise in establishing Development, Qualification, and Production environments with proper segregation. Develop comprehensive Qualification/Validation strategies ensuring GxP compliance throughout the entire integration stack.
4. Quality Management Systems
Comprehensive expertise in establishing and maintaining site-level and company-wide Quality Management Systems (QMS). Deep understanding of GxP requirements across different regulatory regions including FDA, EMA, and ICH guidelines. Experience integrating QMS principles into IT/OT infrastructure, ensuring data integrity, electronic records compliance (21 CFR Part 11, Annex 11), and audit readiness.
5. IT/OT Convergence Excellence
Specialized expertise in bridging the gap between enterprise IT systems and manufacturing operations technology. Creating unified digital ecosystems that drive efficiency, visibility, and data-driven decision-making across global production networks while maintaining regulatory compliance and operational excellence.
Get In Touch
Ready to transform your pharmaceutical operations? Contact us today.
Location
Bernoullistrasse 20
4056 Basel
Switzerland
Phone
Website Under Construction
We're currently building a comprehensive digital platform that will showcase the full capabilities and potential of ITOT-Advice. Our new website will demonstrate the same level of excellence in digital transformation that we bring to our clients' pharmaceutical operations— combining strategic vision, technical expertise, and user-centric design to deliver exceptional results.